+1.11(+1.92%)

-1.10(-0.09%)

-0.05(-0.36%)

0.0000(-0.0000%)

Epizyme (EPZM) Reports Narrower-Than-Expected Loss in Q4

Many high profile tech start-ups are racing to IPO in 2019. Here???s what you should know.

Epizyme, Inc. EPZM incurred loss of 29 cents per share in the fourth quarter of 2018, narrower than the Zacks Consensus Estimate of loss of 49 cents and the year-ago loss of 52 cents.

Share price of the company has gone down 22.3% in the past year.

Quarter in Detail

With no approved products in its portfolio as of now, Epizyme heavily relies on its collaborators for revenues. Collaboration revenues for the fourth quarter of 2018 were $9.7 million compared with no revenues in the fourth quarter of 2017.

Research and development (R&D) expenses decreased 24.5% year over year to $21.8 million in the quarter. This decline was primarily due to decreased clinical trial expenses and discovery-stage research expenses, offset by an increase in tazemetostat manufacturing costs.

General and administrative (G&A) expenses were $12.2 million in the quarter, up 44.4% from the year-ago period, due to rise in medical affairs and commercial costs as a result of organizational development in preparation for tazemetostat commercialization.

Epizyme had $240.3 million of cash, cash equivalents and marketable securities as of Dec 31, 2018, compared with $276.4 million as of Dec 31, 2017. The company expects existing cash, cash equivalents and marketable securities to be sufficient to fund its planned operations in the second quarter of 2020.

Pipeline Update

Epizyme is on track to submit its first new drug application (NDA) submission for tazemetostat for epithelioid sarcoma (ES) in the second quarter of 2019. If approved, tazemetostat will be the first commercially available EZH2 inhibitor and the first treatment specifically indicated for epithelioid sarcoma patients.

In late 2018, Epizyme met the FDA to review its planned registration strategy for tazemetostat in patients with Follicular Lymphoma (FL), who have been previously treated with two or more systemic therapies. Based on this interaction, the company anticipates to report updated data from a phase II study at a medical meeting in mid-2019 and submit an NDA for accelerated approval for this patient population in the fourth quarter of 2019.

In mid-2019, Epizyme is planning to initiate a combination study of tazemetostat with the chemo-free treatment regimen “R2” [Celgene’s CELG Revlimid plus Roche’s RHHBY Rituxan] for the treatment of patients with relapsed/refractory FL, who have received at least one prior therapy. The company is also finalizing plans for a trial of tazemetostat in combination with Rituxan for the treatment of patients with relapsed/refractory FL.

GlaxoSmithKline’s earnings estimates have increased from $2.86 per share to $2.95 for 2019 and from $2.93 to $3.05 for 2020 over the past 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters, the average beat being 3.74%.

Is Your Investment Advisor Fumbling Your Financial Future?

See how you can more effectively safeguard your retirement with a new Special Report, “4 Warning Signs Your Investment Advisor Might Be Sabotaging Your Financial Future.”

Click to get it free >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report